EU chemicals regulation plan is unsustainable

The EU’s new chemical regulation, which involves a comprehensive overhaul of the EU’s chemical law, is known as REACH: an acronym for Registration, Evaluation and Authorisation of Chemicals. Reflecting the precautionary and prevention principles, REACH is aimed at reducing all risks associated with chemicals during their entire life cycle, from manufacture, to use and disposal.

To achieve this objective, REACH would impose onerous obligations on chemical manufacturers, importers, and users. It would cover not only

bulk chemicals – ‘substances’ and ‘preparations’ – but also all products containing chemicals – so-called ‘articles’ – thus, all products. Moreover, it would cover all imports into the EU of both chemicals and products. In designing

the new system, the responsible officials have been guided by the sustainable development concept and the precautionary principle. Unfortunately, these principles do not provide any reliable guidance for developing a sound chemical risk control system.

In practice, the precautionary principle is invoked to support risk regulation where science is ambiguous or absent. Under this ‘theory’, some hypothetical possibility or anecdotal evidence of harm is deemed to justify regulatory intervention, often involving a serious restriction or ban. “The basic truth is,” proponents argue, “that absence of proof of harm is not proof of absence of harm.” The desired side-effect of their logic is a shift of the burden

of proof from the regulator

to the manufacturer. Manufacturers are required

to prove the absence of

risk, which is a logical impossibility.

To justify the REACH regime, EU officials assert that “it is widely accepted that existing legislation needs to be improved in order to meet public concern in Europe about the potential impact of chemicals on health and the environment.” This logic is flawed. Unfounded public concern must be addressed not by regulation but by education, or, in Eurospeak, ‘dialogue’. But even if there were agreement that the current chemical law regime needs to be improved, that does not mean REACH is the

preferred option.

REACH is promoted as the way to a ‘toxic-free’ society. To achieve this objective, the draft regulation would create an unprecedented level of government control over the manufacture and use

of chemicals. The draftsmen of the programme approached the problem

from the wrong angle. They focused on chemicals as the problem, while they should have focused on adverse effects as the problem. They focused on what we do not know, while they should have focused on what we know.

Its proponents assume that generating massive amounts of information, quite apart from the exorbitant cost, will allow the government effectively to reduce overall risks associated with chemicals, thus preventing damage.Much of the data, information, and documents generated under REACH, including data on substances known to be non-dangerous and on ‘intrinsic properties’ – hazards,

as opposed to risks – will be irrelevant to

risk reduction.

Compared to alternative regulatory approaches, this approach is bound to result in higher overall risk levels and more damage because it does not sufficiently concentrate scarce resources on the most serious risks. In addition, the system,

as designed, grossly overestimates the

ability of governments to act on

the massive volumes of information submitted to them.

The misallocation of risk reduction resources required by REACH would be unprecedented in history. If REACH becomes law, Europeans will face much higher risk levels than they should have to face. In the US, which has not adopted any regime that comes even close to the REACH programme, research on the cost-effectiveness of risk regulation has confirmed the dramatic public health consequences of such misallocation.

If the US experience is representative, the REACH regime may well create countervailing risks many times higher than those it controls.

Hopefully, the upcoming changes in the Commission and the shift in the balance of power within the EU post-enlargement will cause serious reconsideration of the REACH regime. If the EU is serious about reducing chemical risk, the REACH team should be sent back to the drawing board to design a regime that is not based on the slogan ‘better safe than sorry’, but allows us to be safe and not sorry.

Lucas Bergkamp is professor of law at Erasmus University, Rotterdam, and managing partner in Hunton & Williams, Brussels.